Folotyn
Generic: PRALATREXATE
Basic Information
Manufacturer
Acrotech Biopharma Inc
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
9f3d9c4d-9386-4451-b712-0fbdc5478d8f
Indications & Usage
1 INDICATIONS AND USAGE FOLOTYN is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
This indication is approved under accelerated approval based on overall response rate [ see Clinical Studies (14) ] .
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
FOLOTYN is a dihydrofolate reductase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
This indication is approved under accelerated approval based on overall response rate.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
( 1 )
This indication is approved under accelerated approval based on overall response rate [ see Clinical Studies (14) ] .
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
FOLOTYN is a dihydrofolate reductase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
This indication is approved under accelerated approval based on overall response rate.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [ see Warnings and Precautions (5.1) ] Mucositis [ see Warnings and Precautions (5.2) ] Dermatologic Reactions [ see Warnings and Precautions (5.3) ] Tumor Lysis Syndrome [ see Warnings and Precautions (5.4) ] Hepatic Toxicity [ see Warnings and Precautions (5.5) ] Most common adverse reactions (>35%) are mucositis, thrombocytopenia, nausea, and fatigue.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Acrotech Biopharma Inc at 1-888-255-6788 or www.FOLOTYN.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Peripheral T-cell Lymphoma The safety of FOLOTYN was evaluated in Study PDX-008 [ see Clinical Studies (14) ] .
Patients received FOLOTYN 30 mg/m 2 once weekly for 6 weeks in 7-week cycles.
The median duration of treatment was 70 days (range: 1 day to 1.5 years).
The majority of patients (69%, n = 77) remained at the target dose for the duration of treatment.
Overall, 85% of scheduled doses were administered.
Forty-four percent of patients (n = 49) experienced a serious adverse event while on study or within 30 days after their last dose of FOLOTYN.
The most common serious adverse events (> 3%), regardless of causality, were pyrexia, mucositis, sepsis, febrile neutropenia, dehydration, dyspnea, and thrombocytopenia.
One death from cardiopulmonary arrest in a patient with mucositis and febrile neutropenia was reported in this trial.
Across clinical trials, deaths from mucositis, febrile neutropenia, sepsis, and pancytopenia occurred in 1.2% of patients who received doses ranging from 30 mg/m 2 to 325 mg/m 2 .
Twenty-three percent of patients (n = 25) discontinued treatment with FOLOTYN due to adverse reactions.
The most frequent adverse reactions reported as the reason for discontinuation of treatment were mucositis (6%) and thrombocytopenia (5%).
The most common adverse reactions (> 35%) were mucositis, thrombocytopenia, nausea, and fatigue.
Table 4 summarizes the adverse reactions in Study PDX-008.
Table 4 Adverse Reactions in (≥ 10%) in Patients Who Received FOLOTYN in Study PDX-008 FOLOTYN N=111 All Grades (%) Grade 3 (%) Grade 4 (%) Any Adverse Event 100 43 31 Mucositis a 70 17 4 Thrombocytopenia b 41 14 19 b Nausea 40 4 0 Fatigue 36 5 2 Anemia 34 15 2 Constipation 33 0 0 Pyrexia 32 1 1 Edema 30 1 0 Cough 28 1 0 Epistaxis 26 0 0 Vomiting 25 2 0 Neutropenia 24 13 7 Diarrhea 21 2 0 Dyspnea 19 7 0 Hypokalemia 15 4 1 Anorexia 15 3 0 Rash 15 0 0 Pruritus 14 2 0 Pharyngolaryngeal pain 14 1 0 Liver function test abnormal c 13 5 0 Abdominal pain 12 4 0 Pain in extremity 12 0 0 Leukopenia 11 3 4 Back pain 11 3 0 Night sweats 11 0 0 Asthenia 10 1 0 Upper respiratory tract infection 10 1 0 Tachycardia 10 0 0 a Mucositis includes stomatitis or mucosal inflammation of the gastrointestinal and genitourinary tracts.
b Five patients with platelets < 10,000/mcL c Liver function test abnormal includes increased ALT, increased AST, and increased transaminases 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of FOLOTYN.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Dermatologic Reactions : Toxic epidermal necrolysis.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Acrotech Biopharma Inc at 1-888-255-6788 or www.FOLOTYN.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Peripheral T-cell Lymphoma The safety of FOLOTYN was evaluated in Study PDX-008 [ see Clinical Studies (14) ] .
Patients received FOLOTYN 30 mg/m 2 once weekly for 6 weeks in 7-week cycles.
The median duration of treatment was 70 days (range: 1 day to 1.5 years).
The majority of patients (69%, n = 77) remained at the target dose for the duration of treatment.
Overall, 85% of scheduled doses were administered.
Forty-four percent of patients (n = 49) experienced a serious adverse event while on study or within 30 days after their last dose of FOLOTYN.
The most common serious adverse events (> 3%), regardless of causality, were pyrexia, mucositis, sepsis, febrile neutropenia, dehydration, dyspnea, and thrombocytopenia.
One death from cardiopulmonary arrest in a patient with mucositis and febrile neutropenia was reported in this trial.
Across clinical trials, deaths from mucositis, febrile neutropenia, sepsis, and pancytopenia occurred in 1.2% of patients who received doses ranging from 30 mg/m 2 to 325 mg/m 2 .
Twenty-three percent of patients (n = 25) discontinued treatment with FOLOTYN due to adverse reactions.
The most frequent adverse reactions reported as the reason for discontinuation of treatment were mucositis (6%) and thrombocytopenia (5%).
The most common adverse reactions (> 35%) were mucositis, thrombocytopenia, nausea, and fatigue.
Table 4 summarizes the adverse reactions in Study PDX-008.
Table 4 Adverse Reactions in (≥ 10%) in Patients Who Received FOLOTYN in Study PDX-008 FOLOTYN N=111 All Grades (%) Grade 3 (%) Grade 4 (%) Any Adverse Event 100 43 31 Mucositis a 70 17 4 Thrombocytopenia b 41 14 19 b Nausea 40 4 0 Fatigue 36 5 2 Anemia 34 15 2 Constipation 33 0 0 Pyrexia 32 1 1 Edema 30 1 0 Cough 28 1 0 Epistaxis 26 0 0 Vomiting 25 2 0 Neutropenia 24 13 7 Diarrhea 21 2 0 Dyspnea 19 7 0 Hypokalemia 15 4 1 Anorexia 15 3 0 Rash 15 0 0 Pruritus 14 2 0 Pharyngolaryngeal pain 14 1 0 Liver function test abnormal c 13 5 0 Abdominal pain 12 4 0 Pain in extremity 12 0 0 Leukopenia 11 3 4 Back pain 11 3 0 Night sweats 11 0 0 Asthenia 10 1 0 Upper respiratory tract infection 10 1 0 Tachycardia 10 0 0 a Mucositis includes stomatitis or mucosal inflammation of the gastrointestinal and genitourinary tracts.
b Five patients with platelets < 10,000/mcL c Liver function test abnormal includes increased ALT, increased AST, and increased transaminases 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of FOLOTYN.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Dermatologic Reactions : Toxic epidermal necrolysis.